Ethical approval
was obtained from the Medical Research and Ethic Committee of Tianjin Medical University Eye hospital. The collection of data in the current study followed the guidelines of the Declaration of Helsinki. All the patients gave their informed consent after being fully explained about the procedure while the personal data remains anonymous. All intraocular surgical procedures in our hospital are videotaped as a routine practice for teaching and learning purposes. As one of the hospital policies, the attending surgeons are encouraged to report the occurrence of posterior capsular rupture and fill out the self-reporting form in the medical record. The clinical audit team reviewed the reported cases every month and provided a monthly report on the intraoperative complications in the staff meeting of the hospital. When the rate of intraoperative complications and PCR increases, the possible causes will be discussed during the staff meeting and the board meeting of safety and quality control of the hospital resulting in the implementation of safety guidelines and measures.
The current study retrospectively reviewed the cases of planned phacoemulsification over a period of 5 years, from August 2015 to October 2020. Eyes with combined trabeculectomy, vitrectomy and keratoplasty were excluded from the study. Demographic data, ocular comorbidities (such as pseudoexfoliation syndrome, angle closure glaucoma, diabetic retinopathy and age-related macular degeneration), intraoperative complications (such as: PCR, zonulysis, aqueous misdirection, iris prolapse, suprachoroidal haemorrhage, dehiscence of Descemet membrane, broken haptic, and amaurosis fugax) were documented for further analysis.
The staged implementation of ambulatory day care surgery units with the redesigning of the floor plan and re-organization of the day care medical team
As an academic tertiary eye hospital, our hospital commenced the implementation of ambulatory day surgery since 2015. The 2nd to 5th floor of the hospital building are in-patient wards which contain 50 beds on each floor as one independent unit with their designated operation rooms. The operating theatre is located on the 6th floor. The transition of in-patient cataract surgery to ambulatory day surgery was staged to 3 consecutive periods. The first stage (stage 1, 2015.8 -2016.12) was the initial implementation of the day surgery for cataract, in which the day surgery patients share the same perioperative care units and the operation rooms with the in-patient surgery in their individual floor. The pre-admission tests including the blood work, EKG and biometry etc. were performed at least 3 days prior to the scheduled surgery. On the scheduled day of surgery, a designated staff nurse performed the preoperative preparation such as the irrigation of the conjunctival sac, vital signs taking and administration of antibiotic and mydriatic eye drops. The medical officer comes to meet the patients for the discussion of the cataract surgery to be done. Afterwards, the patients wait in the day surgery waiting room with their family for the porter to transfer them to the operating theatre. The second stage (stage 2, 2017.1-2019.12) of ambulatory day surgery launched because of the gradually increased numbers of day surgery patients. On each floor, a separated medical unit of nurses are designated to perform the perioperative care for the day surgery patients with the reconfigured reception counter and rooms for admission and pre-operative process. The waiting room remained as before. The third stage (stage 3, 2020.1-2020.10) commenced with two of the hospital floors (the 2nd and 5th floor) being renovated into independent day surgery centers exclusively for day surgery with their designated nursing staff and reception, which was also an adaptation for the prevention of the COVID-19.
The factors that could influence the incidence of intraoperative complications
We tested four non-medical factors that could influence the incidence of intraoperative complications. First, surgery performed in the month containing long holiday (Chinese New Year and National day could indicate the influence of the alteration of the human capital depreciation of the surgical team. Second, surgery performed in the first month of the residents’ rotation may reflex the effect of cohort turnover that compromise the familiarity of the surgical team. The third factor we tested was whether the surgery perform in the month with a sudden increase of surgical volume by 30–50%, 50–100% and more than 100%, which could result in the overload for the workflow. The fourth factor was the stage of the transitional period of the day surgery. The PCR rates were analyzed according to these factors using univariable logistic regression.
Implementation Of Safety Recommendation Based On Clinical Audit Results
To further improve the quality of care provided to our patients, a clinical audit department was established in 2015 as part of the clinical service quality improvement project. The audit team extracts the data from electronic medical records as well as the medical documents to monitor certain benchmarks of the clinical service of various subspecialties, including the incidence of PCR, visual outcomes and surgical complications of phacoemulsification, vitrectomy, trabeculectomy and penetrating keratoplasty monthly. A full analysis of the clinical audit data and report was presented in the quality and safety meeting of the hospital in January 2018, including the increased PCR rate and the risk factors of PCR. The audit team also shared the possible contributing factors that we hypothesized which could impact the intraoperative complication rate, including the age, the preoperative comorbidities, the inadequate communication between the team members and the incoming novice residents. The audit team also recommended the surgeons to be cautious on patient selection when they just came back from vacations more than 7 days. The surgeons were instructed to enhance the preoperative evaluation by filling up the pre-op check list to ensure the identification of the high-risk cases. Additionally, the residents received a more intensive course on the workflow and the perioperative management of cataract patients during the introduction courses before they started their new rotation. The PCR rate before and after the safety recommendation meeting was also analyzed.
Statistical analysis:
Datasets were analyzed using SPSS 22.0 for descriptive and comparative statistics. The frequency and percentage were used to describe the categorical variables. The PCR rate was analyzed according to the following factors: type of surgery (day surgery vs. inpatient surgery), gender, age, surgery performed in the month containing long holiday (Chinese New Year and National day), surgery performed in the first month of the residents’ rotation, increase of surgical volume comparing to the previous month, stage of the day surgery transition and whether it was before or after the implementation of safety recommendation based on clinical audit results in January 2018. The univariable logistic regression model was initially performed. Variables that were statistically significant (p < 0. 01) on the univariate model were then entered into multiple logistic regression model using stepwise regression method (αin = 0.05, αout = 0.10). Adjusted ORs indicating the effect of the risk factors on the occurrence of PCR and complications during cataract surgery were calculated and reported with 95% CI. The code of categorical variables showed in supplementary data (supplementary table 1).